FDA’s ‘Wait and See’ Approach to BPA Not Acceptable — and Not the Only Option

Last Friday, the FDA denied the Natural Resources Defense Council’s (NRDC) citizen petition requesting that the agency ban Bisphenol A (BPA) as an approved food additive and food contact substance.  The agency took nearly three years to issue this decision, and did so only under a court’s order. The FDA’s denial of the petition was disappointing, because the existing science on BPA is strong enough to warrant restrictions on its use. The announcement was an unsurprising continuation of the federal government’s “wait and see” approach to BPA regulation. 

FDA spokesman Douglas Karas said that “this announcement is not a final safety determination and the FDA continues to support research examining the safety of BPA.”  There is no question that continued risk assessment and scientific study of BPA should be part of the FDA’s action plan for addressing the health and safety concerns that recent scientific studies on BPA have raised.  Earlier this year, CPR released a white paper, Protecting the Public from BPA:  An Action Plan for Federal Agencies, providing a list of short-term and long-term actions that federal agencies could take to address some of these mounting concerns about BPA.  At the top of our list for FDA was a continued and aggressive pursuit of the Agency’s collaborative research projects with the National Center for Toxicological Research and the National Toxicology Program.

In the meantime, however, I would remind FDA that a large body of scientific evidence already exists (and continues to collect) that supports increased restrictions on BPA’s use in food contact materials.  FDA itself has taken note of these concerns in its previous statements on BPA.  While FDA may see an all-out ban of this endocrine-disrupting chemical as too extreme or time-consuming, and continued scientific study is indeed imperative, there are a number of safeguards that would provide the public with some protections in the interim – much better than simply a “wait and see” approach.  Here’s what the FDA should do:

• Issue “BPA-Free” Labeling Guidance. “BPA-Free” labels are everywhere but provide consumers with a false sense of security, because BPA is often simply replaced with other endocrine-disrupting chemicals.  FDA should issue labeling guidance on the use of “BPA-Free” labels to ensure that these labels are not misleading or inaccurate and carry some meaningful assurances of protection.  This guidance should include a recommendation that any “BPA-Free” labeled product that merely uses a replacement endocrine-disrupting product would be considered misbranded.
• Issue New Guidance and Use Standards for Food Contact Substance Notification Applicants. Since 2002, packaging uses of BPA have been approved under the Food Contact Substance Notification process.  For any future applicants, FDA could issue guidance stating that any new Food Contact Substance Notification applications for a new BPA use will most likely face denial if the new use involves contact with certain foods, such as infant formula, or a dangerous target consumer, such as children.
• Revoke Existing and New BPA Uses Approved under the Food Contact Substance Notification Process. As a further step, FDA could revoke approved Food Contact Substance Notifications and affirmatively deny applications with the aim of putting a pause on new BPA uses and imposing new safety testing, exposure, and use standards for BPA.  If consumers must wait and see while the safety is affirmed, so too should industry.
• Rewrite Redbook Protocols for BPA and other Endocrine Disruptors. Continued scientific evaluation is imperative, and that research must take into account how BPA and other endocrine disrupting chemicals do not fit the traditional risk assessment mold, where “the dose makes the poison” and higher doses of a chemical lead to increased risks.  Underlying scientific protocols must be rewritten to account for the unique low-dose adverse affects of these chemicals and alternative study endpoints.
• Issue New Regulations for BPA Uses. Beginning in 1958, FDA approved certain uses of BPA as indirect food additives.  FDA has the power to issue new regulations prescribing the conditions under which those uses are deemed safe.  FDA should utilize this authority and issue new regulations outlining specific use and safety parameters for BPA.  While FDA won’t issue an across-the-board ban of BPA at this time, there are a number of more focused regulations that could provide some much needed safeguards. For example, specific uses could be banned, labeling requirements for all materials containing BPA (i.e. let the consumer decide whether they would like BPA in their products), or mandating the submission of specific toxicity and exposure testing information on a regular basis.

Any of these action items would demonstrate a commitment to protecting the public, while also allowing for more scientific research to progress.  It’s time for FDA to act on the part of the people it is meant to protect.